K253675 is an FDA 510(k) clearance for the OsteoRemedies Hip Spacer System. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Osteoremedies, LLC (Germantown, US). The FDA issued a Cleared decision on December 23, 2025, 32 days after receiving the submission on November 21, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K253675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL - Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |